The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0275-2022·Announced 2021-12-15

Fexofenadine and Pseudoephedrine Tablets Recalled for Failed Dissolution

Dr. Reddy's Laboratories is recalling Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg extended-release tablets because they failed to meet dissolution specifications, which may affect how the medication works in the body.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: This is an FDA Class III recall with no reported illnesses or injuries. The hazard is a manufacturing defect (failed dissolution) that is theoretical in nature. There is no evidence of actual harm to consumers, and no serious safety threat is documented in the source text.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg Extended Release Tablets USP, an over-the-counter allergy and congestion medication, due to failed dissolution specifications.

Lot #AC2103329A did not meet the required dissolution standards. When a tablet fails dissolution testing, it may not break down properly in the body, potentially affecting the delivery and effectiveness of the active ingredients.

The recalled product was distributed nationwide in the United States. Approximately 2,928 cartons of 30-tablet packages were affected, with NDC 43598-823-31. The product was manufactured in India and distributed by Dr. Reddy's Laboratories, Inc., Princeton, NJ.

Consumers with this product should stop using it and consult their pharmacy or healthcare provider. The medication should not be used until the issue is resolved.

The recalled product

Product
FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI (FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI)
Brand
FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Over-the-Counter / Allergy & Decongestant
Hazard
Affected units
2,928

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot #: AC2103329A

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 9 recalled by Dr. Reddy's Laboratories, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

Related recalls

Same brand · FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI

Same manufacturer · Dr. Reddy's Laboratories, Inc.

See all →

Same hazard · dissolution failure

See all →

Similar recalls